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Background: The Prostate Cancer Registry is a prospective, international observational study that began in June 2013 and will assess the characteristics and management of > 3000 ...mCRPC patients (pts) in routine clinical practice for ≤ 3 years. Methods: Data were collected from men with mCRPC irrespective of treatment (tx). This interim analysis reports baseline characteristics, txs and outcomes in pts with ≥ 12-month follow-up receiving second-line mCRPC tx following docetaxel as the only prior mCRPC tx. Results: The most commonly initiated second-line mCPRC txs (n ≥ 50) were abiraterone acetate + prednisone (AAP, n = 177), enzalutamide (ENZ, n = 94), or cabazitaxel (CAB, n = 70). Characteristics and outcomes are shown in the table below. TTP was not significantly different for AAP vs ENZ, AAP vs CAB or ENZ vs CAB (propensity score adjusted p = 0.5954, p = 0.5888 and p= 0.4808, respectively). Conclusions: In this real-world study, clinical outcomes reveal that, in pts receiving second-line mCRPC tx after docetaxel, TTP was similar across tx groups; QoL improved most in AAP and ENZ groups and no deterioration was observed most in AAP and CAB groups. Clinical trial information: NCT02236637. Table: see text
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Background: The Prostate Cancer Registry is the first prospective, international observational study in mCRPC documenting characteristics and management in routine clinical ...practice, independent of treatment used. The study began in June 2013 enrolling > 3000 mCRPC patients (pts) followed for ≤ 3 years. Methods: Source-verified data were collected from men with documented mCRPC initiating a new mCRPC treatment or in surveillance. A history of disease progression despite surgical or chemical ADT was confirmed in all pts. This interim analysis reports baseline characteristics, treatments and outcomes in pts with no prior mCRPC treatment. To evaluate comparative effectiveness between treatments, propensity scoring (PS) methods were used to reduce effects of confounding. Results: Of 1906 evaluable pts with ≥ 12-month follow-up, the most commonly initiated first-line mCPRC treatments (n ≥ 50) were abiraterone acetate + prednisone (AA, n = 472), enzalutamide (ENZ, n = 98) or docetaxel (DOC, n = 382). Baseline characteristics, time to progression (TTP) and prostate-specific antigen (PSA) response ( ≥ 50% decrease within 6 months) are shown in the table below. Conclusions: In this real-world study, pts receiving DOC as their first mCRPC treatment had more severe disease at entry and a trend for shorter TTP vs androgen inhibitors. TTP results are consistent with those in randomised clinical trials for AA and ENZ. Clinical trial information: NCT02236637. Table: see text
Disruptive behavior disorders (DBDs), excluding attention deficit/hyperactivity disorder (ADHD), are characterized by a repetitive pattern of antisocial, aggressive, and defiant behavior involving ...major violations of age-appropriate norms, resulting in significant functional impairment. Risperidone is licensed for the treatment of DBDs in children, adolescents, and adults in several countries. The aim of this study was to determine the effect of risperidone in a clinical setting on the symptom items of the Nisonger Child Behavior Rating Form (N-CBRF), used for the assessment of DBD patients.
Data from two 6-week, randomized, double-blind, placebo-controlled trials of risperidone oral solution (0.02-0.06 mg/kg/day) in children with DBDs and subaverage IQ (mild, moderate mental retardation and borderline IQ) were pooled for analysis.
Risperidone produced improvement in both the Social Competence and the Problem Behavior N-CBRF subscales. Risperidone reduced symptoms in the Problem Behavior subscales (e.g., Conduct Problem, Insecure/Anxious) but also improved positive behaviors on the Social Competence subscales. Unlike most problem-behavior items, certain items reflecting "Affective insecurity" (e.g., shy, timid; clings to adults; crying, tearful episodes) failed to improve. This was also true of social disinterest and certain rituals. No items showed any worsening of symptoms with active medication.
Whereas most categories of problem behavior improved with risperidone, items reflecting "affective insecurity" and some infrequently endorsed items were unaffected in these children with DBDs and subaverage IQ. These data may provide a more refined knowledge of risperidone's therapeutic effects in such children.
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